The European Medicines Agency hit a 15-year high for positive drug recommendations in 2024, with 114 new medicines gaining a positive opinion for regulatory approval across the EU from its human medicines committee, the CHMP.
EMA Hits 15-Year Peak With 114 Positive Drug Recommendations In 2024
The European Medicines Agency’s chief medical officer, Steffen Thirstrup, said the surge in positive opinions adopted by the agency in 2024 for new marketing approvals signals a post-COVID recovery.
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The European Medicines Agency has recommended 16 drugs for EU-wide approval, including Vertex’s cystic fibrosis drug Alyftrek and five other orphans.
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Novo Nordisk’s application seeking EU marketing approval to use its GLP-1 receptor agonist to treat cirrhotic metabolic dysfunction-associated steatohepatitis is one of 15 new drug filings the European Medicines Agency has started reviewing. Meanwhile, Arrowhead’s filing for its familial chylomicronemia syndrome, plozasiran, is being fast tracked.
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Nirogacestat was one of four products scheduled for an oral explanation meeting at the European Medicines Agency this week.
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The European Medicines Agency is this week expected issue opinions on whether the European Commission should grant EU marketing authorization for 19 new products.
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A list of EU biosimilar filings, CHMP opinions and EU marketing authorizations, including details of the biosimilar company, the brand name/INN, indication(s), the reference product/company, and the date and type of event.
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The Pink Sheet's list of EU centralized approvals of new active substances has been updated to include four new products, one of which is Tivdak, Pfizer/Genmab’s treatment for previously treated recurrent or metastatic cervical cancer.
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Eisai is working on securing reimbursement across the EU for Leqembi now that the Alzheimer’s disease treatment has secured marketing approval from the European Commission.